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Supportive Care for Breast Cancer
N/A
Waitlist Available
Led By Eileen Hacker, PHD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 3 months
Awards & highlights
Study Summary
This trial is testing an e-health support program to help newly diagnosed breast cancer patients with symptoms like pain, fatigue, depression, and anxiety. The goal is to improve overall health.
Eligible Conditions
- Breast Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Impact of electronic (e)-health support program on patient reported outcomes
Side effects data
From 2021 Phase 2 trial • 63 Patients • NCT0438258617%
Bradycardia
10%
Hypokalaemia
7%
Nausea
7%
Respiratory failure
7%
Constipation
7%
Hyperglycaemia
7%
Diarrhoea
3%
Tachycardia
3%
Decubitus ulcer
3%
Hypovolaemic shock
3%
Sinus tachycardia
3%
Decreased appetite
3%
Epstein-Barr virus infection
3%
Sepsis
3%
Parotitis
3%
Hypoglycaemia
3%
Muscle spasms
3%
Headache
3%
COVID-19 pneumonia
3%
Pulmonary embolism
3%
Anaemia
3%
Leukocytosis
3%
Thrombocytopenia
3%
Extrasystoles
3%
Ascites
3%
Dyspepsia
3%
Flatulence
3%
Rectal haemorrhage
3%
Fatigue
3%
Oedema peripheral
3%
Intensive care unit acquired weakness
3%
Dyspnoea
3%
Pleuritic pain
3%
Sinus bradycardia
3%
Acute kidney injury
3%
Pancytopenia
3%
Distributive shock
3%
Hypoxia
3%
Urinary tract infection
3%
Vision blurred
3%
Hypophosphataemia
3%
Pneumonia bacterial
3%
Rash macular
3%
Cellulitis
3%
Hypophagia
3%
Hepatic enzyme increased
3%
Lymphocyte count decreased
3%
Micturition urgency
3%
Groin pain
3%
Nasal discomfort
3%
Hypoalbuminaemia
3%
Rhabdomyolysis
3%
Back pain
3%
Alopecia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Zanubrutinib + Supportive Care
Placebo + Supportive Care
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Group I (Pack Health Program)Experimental Treatment2 Interventions
Patients participate in the Pack Health Program which includes up to 60 scheduled touch points via phone, text, email and a mobile application and weekly interaction with a health coach over 3 months. They also have access to standard of care support services at MD Anderson including a telephone triage line 5 days a week between 8 a.m. and 5 p.m.
Group II: Group II (standard of care support services)Active Control2 Interventions
Patients receive standard of care support services with a telephone triage line available 5 days a week between 8 a.m. and 5 p.m.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Supportive Care
2013
Completed Phase 2
~1710
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,030 Total Patients Enrolled
148 Trials studying Breast Cancer
63,286 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,227 Total Patients Enrolled
939 Trials studying Breast Cancer
1,543,333 Patients Enrolled for Breast Cancer
Eileen Hacker, PHDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
287 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any openings to join this research endeavor?
"As per clinicaltrials.gov, this research is no longer actively recruiting patients. The trial was initially posted on May 19th 2017; however it hasn't been updated since November 1st 2022. Despite this fact, there are still 2291 other studies currently seeking out participants for enrolment."
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